The EU draft regulation implementing the list of co-formulants that shall not be used in plant protection products or adjuvants (Annex III of Regulation (EC) No. 1107/2009) was discussed in the SCoPAFF meeting of 16 and 17 July 2019.
Co-formulants are unacceptable in plant protection products if it is established that their use or their residues have a harmful effect on human or animal health or have an unacceptable effect on plants or on the environment.
According to the draft list, the following co-formulants are considered as unacceptable:
– substances with a harmonized classification as carcinogens, category 1A or 1B, or as cell mutagens, category 1A or 1B, or as toxic to reproduction, category 1A or 1B,
– substances identified as persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB),
– substances identified as substances of very high concern due to endocrine disrupting properties,
– substances identified as Persistent Organic Pollutants (POP),
– substances restricted under REACH where their use as a co-formulant in plant protection products is covered by the restriction,
– substances already identified as unacceptable co-formulants for plant protection products by Member States (Austria, Belgium, France, Germany, Italy, Lithuania, Spain and Norway) or during the renewal of approval process of active substance (i.e. POE-tallowamines),
– in-can preservatives that were not approved under the Biocide Regulation (EU) No 528/2012 due to unacceptable risks for human health and the environment (i.e. PHMB),
The draft regulation sets that unacceptable co-formulants may be present as unintentional impurities in other co-formulants provided their individual concentration in the finished plant protection product or adjuvant is less than 0.01 % (w/w) unless a different LoQ (Limit of Quantification) is provided.
At last, the draft Regulation sets that Member States must withdraw authorisations of products containing any of the listed unacceptable co-formulants at the latest by 2 years after entry into force of the list. A grace period of 12 months may be granted.
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